On 12 February 2025, Pfizer announced that the US FDA has approved Adcetris® (brentuximab vedotin) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL). Specific indications include treatment for patients with:
- diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS);
- DLBCL arising from indolent lymphoma; and
- high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not eligible for autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor (CAR) T-cell therapy.
The approval is based on data from the Phase 3 ECHELON-3 study, which demonstrated that patients with relapsed/refractory DLBCL who were treated with Adcetris® in combination with lenalidomide and rituximab achieved a statistically significant and clinically meaningful improvement in overall survival.